Quality Assurance Manager
Miami
Pharma
$120,000
Job Summary:
Our client is seeking a detail-oriented and experienced Quality Assurance (QA) Mid Manager to join the team in Miami, FL. The ideal candidate will have significant experience in Quality Management Systems (QMS), with a strong focus on working with computer systems, implementations, complaints handling, metrics analysis, and quality system management investigations. This role requires a proactive leader who can manage deviations, oversee batch records systems, and ensure compliance with regulatory standards.
Key Responsibilities
Quality Management System (QMS):
- Lead the management and continuous improvement of the QMS, particularly in areas related to computer systems and their implementation.
- Ensure that all quality processes are aligned with regulatory standards and company policies.
Computer Systems Implementation:
- Oversee the implementation and validation of computerized systems within the quality management framework.
- Collaborate with IT and other departments to ensure that systems meet regulatory and operational requirements.
Complaints Handling:
- Manage the complaints process, ensuring timely investigation, root cause analysis, and resolution.
- Develop and maintain systems to track and trend complaints, implementing corrective and preventive actions as needed.
Metrics and Reporting:
- Develop, track, and analyze key quality metrics to monitor the effectiveness of the QMS.
- Provide regular reports to senior management, identifying trends, areas for improvement, and progress on quality initiatives.
Investigations and Deviations:
- Lead and manage investigations into quality issues, deviations, and non-conformances.
- Ensure thorough documentation and implementation of corrective and preventive actions (CAPAs).
Batch Records Management:
- Oversee the review and approval of batch records to ensure compliance with GMP regulations.
- Collaborate with production teams to resolve any issues related to batch documentation.
Compliance and Audits:
- Prepare for and participate in internal and external audits, ensuring the readiness of all quality systems.
- Implement audit findings and maintain a state of continual audit readiness.
Qualifications:
- Education: Bachelor’s degree in a relevant scientific or engineering discipline.
- Experience: Minimum of 5-7 years of experience in quality assurance within the pharmaceutical industry, with at least 2 years in a supervisory or managerial role.
- Technical Skills:
- Extensive experience with QMS, particularly in relation to computerized systems and implementations.
- Strong knowledge of regulatory requirements (FDA, GMP) and quality standards.
- Proficient in managing complaints, investigations, deviations, and batch record systems.
- Experience with quality metrics and data analysis.
- Leadership Skills: Proven ability to lead, mentor, and develop a team, with strong problem-solving and decision-making capabilities.
- Communication Skills: Excellent verbal and written communication skills, with the ability to interact effectively with cross-functional teams and senior management.
